Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Leukemia Clinical Trial

Official title:

Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00943709
• Other study ID #: 060601
• Secondary ID: AVENTIS-CINJ-060
• Status: Withdrawn
• Phase: Phase 3
• First received: July 21, 2009
• Last updated: August 29, 2013
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.

PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Description:

OBJECTIVES:

Primary

• To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Secondary

• To compare the number of episodes of infection.

• To compare the duration of neutropenia.

• To compare the number of days of bacteremia/fungemia.

• To compare the number of days of fever.

• To compare the duration of nutrition.

• To compare the duration of mucositis.

• To compare the duration of hospital stay.

• To compare the duration of antibiotic use.

• To compare the incidence of thromboembolic events.

• To compare body weight changes.

• To compare the median survival.

• To compare the remission rate with induction or salvage chemotherapy.

• To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

• Arm I (intensive glycemic control): Patients with goal blood glucose 80-140 mg/dL receive the Robert Wood Johnson University Hospital IV insulin infusion protocol to maintain blood glucoses in the target range. Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed. Patients may also receive insulin in the total parenteral nutrition (TPN) mixture.

• Arm II (standard care control): Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Insulin may also be added to TPN if needed at the investigator's discretion.

After completion of study treatment, patients are followed up for 4 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia

• Newly diagnosed or relapsed disease

• Undergoing induction or salvage chemotherapy treatment

• Must demonstrate 2 random blood sugars of = 140 mg/dL while on total parenteral nutrition (TPN) OR 2 preprandial sugars of = 140 mg/dL if patient is not on TPN

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3

• Not pregnant or nursing

• Negative pregnancy test

• Prior diagnosis of diabetes mellitus allowed

• No known history of an allergy to insulin

• No documented active infection

PRIOR CONCURRENT THERAPY:

• Concurrent corticosteroids allowed

• No concurrent oral hypoglycemic agents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Leukemia

Intervention

Biological:
• insulin glargine recombinant
Given subcutaneously

Drug:
• therapeutic insulin
Given subcutaneously

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI), Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new infections		4 years	No
Secondary	Number of episodes of infection		4 years	No
Secondary	Duration of neutropenia		4 years	No
Secondary	Number of days of bacteremia/fungemia		4 years	No
Secondary	Number of days of fever		4 years	No
Secondary	Duration of nutrition		4 years	No
Secondary	Duration of mucositis		4 years	No
Secondary	Duration of hospital stay		4 years	No
Secondary	Duration of antibiotic use		4 years	No
Secondary	Incidence of thromboembolic events		4 years	No
Secondary	Body weight changes		4 years	No
Secondary	Median survival		4 years	No
Secondary	Remission rate with induction or salvage chemotherapy		4 years	No
Secondary	Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring		4 years	No